Pediatric Inguinal HerniaDETHREATNCT07106515
Development of Taxi Teaching for Strangled Inguinal Hernias in Children
An observational study of Pediatric Inguinal Hernia, run by University Hospital, Angers.
Trial summary
Inguinal hernias in children are very common but pose a risk of strangulation, which, if not treated quickly, can lead to life-threatening complications (intestinal obstruction, peritonitis) or functional complications (testicular ischemia). Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Pediatric Inguinal Hernia
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with strangulated inguinal hernia presenting at hospital in western France
Who may be able to join
- Any child (pediatric population defined as under 16 years of age) presenting at a university hospital or hospital in western France with a clinical diagnosis of strangulated inguinal hernia
Who cannot join
- Refusal to participate in the search for legal representatives
- Differential diagnosis of strangulated inguinal hernia (adenopathy, cord cyst, cryptorchid testicle, unstrangulated hernia)
- Patients and/or parents who do not speak French
- Patients not affiliated with a social security system.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Inguinal hernias in children are very common but pose a risk of strangulation, which, if not treated quickly, can lead to life-threatening complications (intestinal obstruction, peritonitis) or functional complications (testicular ischemia). The manual reduction of a strangulated inguinal hernia, known as taxis, is often unfamiliar to the first doctors to see the child, whether they are general practitioners, pediatricians, or emergency physicians, and therefore requires second- or third-line treatment, which prolongs the delay in care and increases the risk of serious complications. The hypothesis is that targeted professional training using mannequins to practice this reduction maneuver for the doctors concerned would reduce the time required for reduction and thus improve the care of these patients. To this end, and in the absence of a dedicated model on the market for medical education through simulation, investigatores are developing a pediatric manikin to train doctors in performing hernia reduction maneuvers.
The aim of this study is therefore to compare the care pathway for children with strangulated inguinal hernias before and after training on mannequins for doctors in therapeutic taxis, in order to demonstrate in real life the impact of procedural training through simulation on improving patient care.
Read the detailed description
The objective is to show that a better understanding of hernia reduction techniques by frontline physicians leads to a reduction in the time taken to reduce strangulated inguinal hernias in children consulting for this reason. Investigators will therefore compare the time taken to reduce the hernia before and after the doctors concerned learned the reduction procedure, in the population of children treated for strangulated inguinal hernias in a pediatric surgery department of the HUGO network (Hôpitaux Universitaire du Grand Ouest - University Hospitals of western France). The study will therefore be divided into two phases: an initial retrospective, multicenter phase covering the period prior to the training of physicians in hernia reduction techniques, followed by a prospective, multicenter phase covering the period after training.
- Conditions
- Pediatric Inguinal Hernia
- Keywords
- Strangulated hernia, External hernia reduction maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients before doctors were trained in hernia reduction procedures | Not described | |
| patients after doctors were trained in hernia reduction procedures | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia reduction time
hernia reduction time in children with stranglutated hernia presenting in a hospital of western France before and after the doctors learned the reduction hernia maneuver.
Measured: 6 month
Secondary outcomes (1)
Overal success rate of hernia reduction
The overall success rate of hernia reduction by external reduction maneuver based on the status of the operator (having participated in training or not having participated in training)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Louise RENOULT, Study chair, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106515
- Sponsor's protocol ID
- 49RC25_0085
- Acronym
- DETHREAT
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Taxi Teaching for Strangled Inguinal Hernias in Children
- ClinicalTrials.gov ID
- NCT07106515
- Acronym / sponsor ID
- DETHREAT / 49RC25_0085
- Conditions
- Pediatric Inguinal Hernia
- Keywords
- Strangulated hernia, External hernia reduction maneuver
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inguinal hernias in children are very common but pose a risk of strangulation, which, if not treated quickly, can lead to life-threatening complications (intestinal obstruction, peritonitis) or functional complications (testicular ischemia). The manual reduction of a strangulated inguinal hernia, known as taxis, is often unfamiliar to the first doctors to see the child, whether they are general practitioners, pediatricians, or emergency physicians, and therefore requires second- or third-line treatment, which prolongs the delay in care and increases the risk of serious complications. The hypothesis is that targeted professional training using mannequins to practice this reduction maneuver for the doctors concerned would reduce the time required for reduction and thus improve the care of these patients. To this end, and in the absence of a dedicated model on the market for medical education through simulation, investigatores are developing a pediatric manikin to train doctors in performing hernia reduction maneuvers.
The aim of this study is therefore to compare the care pathway for children with strangulated inguinal hernias before and after training on mannequins for doctors in therapeutic taxis, in order to demonstrate in real life the impact of procedural training through simulation on improving patient care.
Detailed description
The objective is to show that a better understanding of hernia reduction techniques by frontline physicians leads to a reduction in the time taken to reduce strangulated inguinal hernias in children consulting for this reason. Investigators will therefore compare the time taken to reduce the hernia before and after the doctors concerned learned the reduction procedure, in the population of children treated for strangulated inguinal hernias in a pediatric surgery department of the HUGO network (Hôpitaux Universitaire du Grand Ouest - University Hospitals of western France). The study will therefore be divided into two phases: an initial retrospective, multicenter phase covering the period prior to the training of physicians in hernia reduction techniques, followed by a prospective, multicenter phase covering the period after training.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients before doctors were trained in hernia reduction procedures | – | – |
| patients after doctors were trained in hernia reduction procedures | – | – |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with strangulated inguinal hernia presenting at hospital in western France
Key inclusion criteria (1 listed)
- Any child (pediatric population defined as under 16 years of age) presenting at a university hospital or hospital in western France with a clinical diagnosis of strangulated inguinal hernia
Key exclusion criteria (4 listed)
- Refusal to participate in the search for legal representatives
- Differential diagnosis of strangulated inguinal hernia (adenopathy, cord cyst, cryptorchid testicle, unstrangulated hernia)
- Patients and/or parents who do not speak French
- Patients not affiliated with a social security system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hernia reduction time
Time frame: 6 month
hernia reduction time in children with stranglutated hernia presenting in a hospital of western France before and after the doctors learned the reduction hernia maneuver.
1 secondary outcome
Overal success rate of hernia reduction
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise RENOULT study chair
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Inguinal Hernia, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise RENOULT (2 41 35 42 90 ext. +33, louise.renoult@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia reduction time (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.